BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    S11103 Pajunk Labeled Safersonic Single

    Reg #: 3003623887 · FEI: 3003623887 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PHARMASEPT LTD. MEDICAL PRODUCTS
    Registration Number
    3003623887
    FEI Number
    3003623887
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9 Shaham St., Northern Industrial Park
    City
    Caesarea Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K092858

    Owner / Operator

    Firm Name
    PHARMASEPT LTD. MEDICAL PRODUCTS
    Operator Number
    9045710
    Address
    9 Shaham St., Northern Industrial Park
    City
    Caesarea
    State
    IL-NOTA
    Postal Code
    3088900
    Country
    IL

    US Agent

    Business Name
    Regulatory Insight, Inc.
    Contact Name
    Kevin Walls
    Address
    33 Golden Eagle Lane
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 9625412

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    S11103 Pajunk Labeled Safersonic Single S11104 Pajunk Labeled Safersonic Conti DAN-33825 Safersonic Long DAN-33825U Safersonic Long Non Sterile DAN-33803NT Safersonic Single - No Tape DAN-33805 Safersonic Medium DAN-33812U Safersonic Conti Non Sterile DAN-33803 Safersonic Single DAN-33803U Safersonic Single Non Sterile DAN-33812 Safersonic Conti DAN-33805U Safersonic Medium Non Sterile

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)